Drug Recalls

Central Admixture Pharmacy Services, Inc.

Class II Terminated

CARDIOPLEGIA SOLUTION 122 mEq K, Modified St. Thomas Formula High Potassium, Total Volume = 1000 mL, IV Bag, Rx only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 850...

Reason: Lack of assurance of sterility. Validation data for decontamination cycles is lacking.

D-1030-2023 August 9, 2023 Phoenix, AZ

Central Admixture Pharmacy Services, Inc.

Class II Terminated

Neonatal TPN Starter Bag, Amino Acids (trophamine) 3%/Dextrose 10% with CALCIUM, total volume = 250mL, IV Bag, Rx only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 8...

Reason: Lack of assurance of sterility. Validation data for decontamination cycles is lacking.

D-0999-2023 August 9, 2023 Phoenix, AZ

Central Admixture Pharmacy Services, Inc.

Class II Terminated

Cardioplegia Solution del Nido Formula, IV Bag, Total Volume = 1,052.8 mL, FOR INTRACARDIAC PERFUSION USE ONLY, PLASMA-LYTE A 1000 mL, Mannitol 20% 16.3 mL, Sodium Bicarbonate 8.4% 13 mL, Potassium Ch...

Reason: Lack of assurance of sterility. Validation data for decontamination cycles is lacking.

D-0956-2023 August 9, 2023 Phoenix, AZ

Central Admixture Pharmacy Services, Inc.

Class II Terminated

Neonatal TPN Starter Bag, Amino Acids (Trophamine) 3.5%/Dextrose 10% with CALCIUM and HEPARIN, IV Bag, total volume = 250mL, Rx only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue,...

Reason: Lack of assurance of sterility. Validation data for decontamination cycles is lacking.

D-1008-2023 August 9, 2023 Phoenix, AZ

Central Admixture Pharmacy Services, Inc.

Class II Terminated

potassium phosphate, 30 mmole added to 0.9% sodium Chloride 500mL, IV Bag, RX Only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-7016-1

Reason: Lack of assurance of sterility. Validation data for decontamination cycles is lacking.

D-0990-2023 August 9, 2023 Phoenix, AZ

Central Admixture Pharmacy Services, Inc.

Class II Terminated

CARDIOPLEGIA SOLUTION, 12 mEq K, Maintenance 4:1 in Ringer's Low Potassium, IV Bag, total volume = 504.8 mL, Rx only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 850...

Reason: Lack of assurance of sterility. Validation data for decontamination cycles is lacking.

D-1035-2023 August 9, 2023 Phoenix, AZ

Central Admixture Pharmacy Services, Inc.

Class II Terminated

glycopyrrolate 1 mg/5 mL (0.2 mg/mL), For Anesthesia Use, Syringe, RX ONLY, CAPS, Inc., 2200 South 43rd Avenue, Phoenix, AZ 85043, NDC: 72196-6084-1

Reason: Lack of assurance of sterility. Validation data for decontamination cycles is lacking.

D-0952-2023 August 9, 2023 Phoenix, AZ

Central Admixture Pharmacy Services, Inc.

Class II Terminated

Neonatal TPN Starter Bag, Amino Acids (trophamine) 2.5%/Dextrose 10%, total volume = 250mL, IV Bag, Rx only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: ...

Reason: Lack of assurance of sterility. Validation data for decontamination cycles is lacking.

D-0995-2023 August 9, 2023 Phoenix, AZ

Central Admixture Pharmacy Services, Inc.

Class II Terminated

EPINEPHrine, 2 mg added to dextrose 5% 250mL, Concentration = 8 mcg/mL, IV Bag, Rx Only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Phoenix, AZ 85043, NDC: 72196-6030-1.

Reason: Lack of assurance of sterility. Validation data for decontamination cycles is lacking.

D-0957-2023 August 9, 2023 Phoenix, AZ

Central Admixture Pharmacy Services, Inc.

Class II Terminated

vancomycin 1.5 g/500 mL added to 0.9% sodium chloride, 3 mg/mL, IV Bag, Rx only, Cental Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-6176-1

Reason: Lack of assurance of sterility. Validation data for decontamination cycles is lacking.

D-0967-2023 August 9, 2023 Phoenix, AZ

Central Admixture Pharmacy Services, Inc.

Class II Terminated

CARDIOPLEGIA SOLUTION, 25 mEq K, SUTTER CARDIOPLEGIA, IV Bag, Total Volume = 572.64 mL, Rx only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-0217-1

Reason: Lack of assurance of sterility. Validation data for decontamination cycles is lacking.

D-1021-2023 August 9, 2023 Phoenix, AZ

Central Admixture Pharmacy Services, Inc.

Class II Terminated

Neonatal TPN Starter Bag, Amino Acids (Trophamine) 2.5%/Dextrose 10% with CALCIUM and HEPARIN, total volume = 250mL, IV Bag, Rx only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue,...

Reason: Lack of assurance of sterility. Validation data for decontamination cycles is lacking.

D-0996-2023 August 9, 2023 Phoenix, AZ

Central Admixture Pharmacy Services, Inc.

Class II Terminated

Neonatal TPN Starter Bag, Amino Acids (trophamine) 2%/Dextrose 10% with CALCIUM, total volume = 250mL, IV Bag, Rx only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 8...

Reason: Lack of assurance of sterility. Validation data for decontamination cycles is lacking.

D-0992-2023 August 9, 2023 Phoenix, AZ

Central Admixture Pharmacy Services, Inc.

Class II Terminated

Neonatal TPN Starter Bag, Amino Acids (trophamine) 2%/Dextrose 10% with **low calcium** and HEPARIN, IV Bag, total volume = 250mL, Rx only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd A...

Reason: Lack of assurance of sterility. Validation data for decontamination cycles is lacking.

D-0991-2023 August 9, 2023 Phoenix, AZ

Central Admixture Pharmacy Services, Inc.

Class II Terminated

CARDIOPLEGIA SOLUTION, 100 mEq K, Induction 8:1, High Potassium / Low dextrose, IV Bag, total volume = 500 mL, RX Only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 8...

Reason: Lack of assurance of sterility. Validation data for decontamination cycles is lacking.

D-1031-2023 August 9, 2023 Phoenix, AZ

Central Admixture Pharmacy Services, Inc.

Class II Terminated

CARDIOPLEGIA SOLUTION, low K, Maintenance 4:1 Plasmalyte/Tromethamine, Low Potassium, IV Bag, total volume = 1000 mL, Rx only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheoni...

Reason: Lack of assurance of sterility. Validation data for decontamination cycles is lacking.

D-1038-2023 August 9, 2023 Phoenix, AZ

Central Admixture Pharmacy Services, Inc.

Class II Terminated

vancomycin 1.25 g/250 mL added to dextrose 5%, 5 mg/mL, IV Bag, Rx only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Phoenix AZ 85043, NDC: 72196-6073-1

Reason: Lack of assurance of sterility. Validation data for decontamination cycles is lacking.

D-0950-2023 August 9, 2023 Phoenix, AZ

Central Admixture Pharmacy Services, Inc.

Class II Terminated

CARDIOPLEGIA SOLUTION, 15 mEq K, Reperfusate 4:1, low potassium/low tromethamine, total volume = 500mL, Rx only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, ...

Reason: Lack of assurance of sterility. Validation data for decontamination cycles is lacking.

D-1020-2023 August 9, 2023 Phoenix, AZ

Central Admixture Pharmacy Services, Inc.

Class II Terminated

CARDIOPLEGIA SOLUTION, 70 mEq K, Modified St. Thomas Formula low potassium, IV Bag, Total Volume = 1000 mL, Rx only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 8504...

Reason: Lack of assurance of sterility. Validation data for decontamination cycles is lacking.

D-1033-2023 August 9, 2023 Phoenix, AZ

Central Admixture Pharmacy Services, Inc.

Class II Terminated

phenylephrine, 25mg added to 0.9% sodium chloride 250 mL, IV Bag, Rx Only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Phoenix, AZ 85043, NDC: 72196-7011-1.

Reason: Lack of assurance of sterility. Validation data for decontamination cycles is lacking.

D-0962-2023 August 9, 2023 Phoenix, AZ

Central Admixture Pharmacy Services, Inc.

Class II Terminated

norepinephrine, 16 mg, added to dextrose 5% 250 mL, IV Bag, CONCENTRATION 64 mcg/mL, Rx Only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC 72196-8095-1

Reason: Lack of assurance of sterility. Validation data for decontamination cycles is lacking.

D-0988-2023 August 9, 2023 Phoenix, AZ

Central Admixture Pharmacy Services, Inc.

Class II Terminated

EPINEPHrine added to dextrose 5%, 4mg/250ml, IV Bag, Rx Only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Phoenix, AZ 85043, NDC: 72196-7018-1.

Reason: Lack of assurance of sterility. Validation data for decontamination cycles is lacking.

D-0958-2023 August 9, 2023 Phoenix, AZ

Central Admixture Pharmacy Services, Inc.

Class II Terminated

vancomycin 2 g/500 mL added to 0.9% Sodium Chloride, 4 mg/mL, IV Bag, Rx only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Phoenix, AZ 85043, NDC: 72196-6078-1

Reason: Lack of assurance of sterility. Validation data for decontamination cycles is lacking.

D-0970-2023 August 9, 2023 Phoenix, AZ

Central Admixture Pharmacy Services, Inc.

Class II Terminated

CARDIOPLEGIA SOLUTION, 7.5 mEq K, Reperfusate 4:1, low potassium, IV Bag, total volume = 238.75 mL, Rx only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC:...

Reason: Lack of assurance of sterility. Validation data for decontamination cycles is lacking.

D-1023-2023 August 9, 2023 Phoenix, AZ

Central Admixture Pharmacy Services, Inc.

Class II Terminated

oxyTOCIN 30 units added to Lactated Ringer's 500 mL, IV Bag, Rx only, Rx only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-6039-1

Reason: Lack of assurance of sterility. Validation data for decontamination cycles is lacking.

D-1012-2023 August 9, 2023 Phoenix, AZ

FDA Enforcement Report